Kidney Health: Eat Well, Live Well

NCT05970341 | Recruiting

• 1 other identifier: STUDY00002253
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 3

Brief Summary

This two-arm, parallel randomized trial study will assess the efficacy of a 6-month (26 weeks) community-based program in reducing kidney injury (as Urine Albumin to Creatinine ratio, uACR), cardiovascular risk (as Hemoglobin A1C and blood pressure), mental health (as PHQ-8) and diet quality (as fruits and vegetables intake and Healthy Eating Index) in community-dwelling, low-income adults diagnosed with early chronic kidney disease (stages 2 or 3 and not on kidney replacement therapies) compared to educational materials and usual care alone.

Conditions

Chronic Kidney Diseases

Keywords

phone calls; Telehealth; Fruits and vegetables; Produce; Home delivery; grocery vouchers; gift cards; Community-based trial; Proteinuria; Diet; mental health

Outcome Measures

Primary Outcomes (1)

• Urine albumin:creatinine ratio (UACR)

  Marker of kidney damage and a useful predictor of cardiovascular (CV) events in adults. Uses spot urine to estimate 24-hour urine albumin excretion. UACR \> 30 mg/g indicates kidney damage.

  Baseline, 3 months, 6 months

Secondary Outcomes (7)

• Hemoglobin A1C

  Baseline, 3 months, 6 months

• Blood pressure (systolic/diastolic)

  Baseline, 3 months, 6 months

• Food intake in the past 30 days as assessed by the Dietary Screener Questionnaire from NHANES 2009-10

  Baseline, 3 months, 6 months

• Changes in diet quality as estimates of individual mean dietary intake and frequency of fruits and vegetables consumption

  Baseline, 3 months, 6 months

• Anxiety as measured by scores on the Generalized Anxiety Disorder 7-item (GAD-7)

  Baseline, 3 months, 6 months

Other Outcomes (15)

• Social engagement as measured by the Lubben Social Network scale 6-item

  Baseline, 6 months

• Perception of kidney disease and role of diet as measured by the Brief Illness Perception Questionnaire

  Baseline, 6 months

• General health and quality of life as measured by scores on the MOS Short-form 12-item (SF-12)

  Baseline, 6 months

Study Arms (2)

Arm 1: Intervention + usual care

EXPERIMENTAL

1. Welcome package 2. Welcome information: telephone call 3. Produce delivered at their choice of time and location + Recipes customized to produce 4. E-gift cards to a grocery store of choice 5. Personalized practical, emotional \& educational support through a dedicated health partner

Behavioral: 1. Welcome package; Behavioral: 2. Welcome information (phone or text); Behavioral: 3. Produce delivery + Recipes customized to produce; Behavioral: 4. E-gift cards to a grocery store of choice; Behavioral: 5. Personalized practical & emotional support through a dedicated health partner

Arm 2: Educational materials + usual care

OTHER

1. Welcome package 2. Welcome information: SMS/Text

Behavioral: 1. Welcome package; Behavioral: 2. Welcome information (phone or text)

Interventions

1. Welcome package BEHAVIORAL

At the end of the baseline data collection visit at the clinic, the Research Staff will hand the participant a welcome packet that includes: * educational and motivational written materials (about such topics as CKD and healthy eating for early CKD stages) * a collection of recipes featuring kidney-friendly vegetables

Arm 1: Intervention + usual care; Arm 2: Educational materials + usual care

2. Welcome information (phone or text) BEHAVIORAL

Those allocated to the intervention arm will receive a welcome call from the Program Staff to provide further details and expectations about the program (such as delivery details and schedule). Those allocated to the control arm will receive an SMS text that informs them of their arm allocation, what to expect and a phone number to call for questions.

Arm 1: Intervention + usual care; Arm 2: Educational materials + usual care

3. Produce delivery + Recipes customized to produce BEHAVIORAL

* Content: Bags with kidney-friendly produce will include 2 vegetables sufficient for 2 meals for 4 people, 1 type of fruit, and 1 dried fruit. The total cost is estimated at USD 20, excluding delivery, for prices in June 2022. * Delivery: Bags will be delivered to the participant's preferred location (e.g. home or work) and period of the day (e.g., morning, evening). * Recipes: SMS texts will precede each delivery to share an URL to recipes customized to the items being delivered, and to inform of an upcoming produce bag, its content. * Frequency: 1. Weeks 1-2 (2 weeks): No bags delivered. 2. Weeks 3-10 (8 weeks): Delivered weekly, for a total of 8 bags. 3. Weeks 11-18 (8 weeks): Delivered every two weeks, for a total of 4 bags. 4. Weeks 19-26 (8 weeks): No bags delivered.

Arm 1: Intervention + usual care

4. E-gift cards to a grocery store of choice BEHAVIORAL

Five (5) e-gift cards to a major local grocery retailer chosen by the participant (from 3 options) at the following frequency: 1. Weeks 1-6: No e-gift card. 2. Week 7: One card of USD 30.00 value. 3. Week 11 \& 15: One card of USD 40.00, for a total of USD 80.00. 4. Week 19 \& 23: One card of USD 60.00, for a total of USD 120.00.

Arm 1: Intervention + usual care

5. Personalized practical & emotional support through a dedicated health partner BEHAVIORAL

* Each participant is assigned a program staff ("dedicated health partner") who call them briefly (15 min or so) over the phone for empathy-based support on the participant's health journey, and practical suggestions for shopping and food preparation. * The Health Partner will share periodically via SMS text a curated list of evidence-based, trustworthy online educational resources. * Health partners are not trained to answer medical or health-related questions and will not provide medical guidance or advice of any kind. For such questions, they will encourage participants to contact the clinic or physician. * Frequency: 1. Weeks 1-2 (2 weeks): No calls. 2. Weeks 3-7 (4 weeks): 2 calls a week, for a total of 8 calls. 3. Weeks 8-26 (18 weeks): 1 call every 2 weeks, for a total of 10. But during weeks 7, 11, and 19, participants will be given the choice to keep at 1x/week or decrease to 1x every 4 weeks.

Arm 1: Intervention + usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (18 years of age or older)
• Primary care visit at either one of the three partner clinics from Harris Health \[Smith Clinic, Harris Health Outpatient Center (located on the LBJ campus), or Martin Luther King Jr. Health Center (MLK)\] and a primary care patient within Harris Health System
• Have had at least 1 visit in the past 18 months with prior history in the clinic (i.e., not first visit)
• Diagnosis of CKD (Stage 2, 3a, and 3b) as defined by estimated Glomerular Filtration Rate (eGFR) ≥ 30 and \<90 mL/min/1.73 m2 OR CDK 1 or undiagnosed with urine Albumin Creatinine Ratio ≥ 30 mg/g
• Within the past 12 months, the most current serum K+ ≤ 4.6 mEq/L
• English or Spanish speaking
• Ability to participate in the program at least 6 months
• Ability to clean, prepare, refrigerate/freeze food products that are given to them
• Have access to receive SMS text messages
• Location of preferred produce bag delivery within an available delivery zone

You may not qualify if:

• CKD 4, ESRD or on dialysis.
• Taking certain medications chronically (more than twice a week for 90 days) that may interfere with K+ metabolism (such as non-steroidal anti-inflammatory drugs (NSAIDs), as self-reported during enrollment screening
• Taking mineralocorticoid receptor antagonists
• Taking Warfarin
• Diagnosis of any specific kidney conditions (such as polycystic kidney disease, glomerulonephritis, Lupus associated with Nephritis, Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV)) that would contraindicate study participation as determined by physician
• Medical history of organ transplant that would contraindicate study participation as determined by physician
• Received immunotherapy for primary or secondary kidney disease within 6 months prior to enrolment
• Diagnostic of heart failure conditions Class IV in the New York Heart Association (NYHA) functional classification
• Had myocardial infarction, unstable angina, stroke, or transient ischemic attack (TIA) within 12 weeks prior to enrolment
• Had coronary revascularization (PCI, CABG) or valvular repair within 12 weeks prior to enrolment
• On active hospice care as self-reported during enrollment screening
• Diagnosis of active malignancy requiring treatment that would contraindicate study participation as determined by physician
• Has decompensated cirrhosis as determined by physician
• Cognitive impairment that would contraindicate study participation as self-reported during enrollment screening

Sponsors & Collaborators

• University of Texas at Austin: lead
• Harris Health: collaborator

Study Sites (3)

Harris Health System's Outpatient Center

Houston, Texas, 77026, United States

RECRUITING

Harris Health System's Martin Luther King Jr. Health Center

Houston, Texas, 77047, United States

RECRUITING

Harris Health System's Smith Clinic

Houston, Texas, 77054, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Proteinuria; Psychological Well-Being

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms; Personal Satisfaction; Behavior

Study Officials

• Maninder Kahlon, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Courtney Mulligan, MA

CONTACT

512-522-4349; Courtney.Mulligan@austin.utexas.edu

Nicole Clark, MBA

CONTACT

210-316-5443; nicole.clark@austin.utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research staff responsible for biomedical data collection at the sites are blinded to the participant's allocation group. Surveys are primarily self-administered on an electronic mobile device (e.g., tablet, laptop). For participants who require help reading and/or using the device, survey data will be collected via structured interview.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Population Health

Model Details: Community-based randomized controlled trial stratified by self-reported diabetes diagnosis at baseline.

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: December 6, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

US (3)